WuXi XDC Cayman Inc. (HKG: 2268), a China-based global Contract Research, Development and Manufacturing Organisation (CRDMO) involved in the bioconjugate industry, announced on Tuesday that its BCM3 dual-function production line for antibody intermediates and drug substances of bioconjugates at Singapore site has successfully achieved Good Manufacturing Practices (GMP) release.
The company says that this milestone marks a new phase in its global capacity expansion, empowering clients worldwide to accelerate commercial manufacturing with greater efficiency and flexibility in meeting diverse demands.
According to Wuxi, as its first overseas GMP-released facility, BCM3 features an efficient and flexible 'dual-function' design, offering integrated end-to-end commercial manufacturing services from antibody intermediates to conjugated drug substances. The production line supports batch sizes from 200 L to 2,000 L for antibody intermediates, and up to 2,000 L for conjugated drug substances, fully meeting commercial-scale requirements while adhering to a rigorous quality control system. As a critical component of WuXi XDC's global manufacturing network, BCM3 will work in synergy with the BCM1 and BCM2 lines at the Wuxi site, substantially boosting overall capacity for both antibody intermediates and conjugated drug substances.
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